Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio) has officially announced the approval of its Investigational New Drug (IND) application by the National Medical Products Administration (NMPA) for the innovative antibody drug AK0610. This revolutionary antibody drug is a result of bioengineering, originating from a neutralizing antibody found in a child who had previously recovered from respiratory syncytial virus (RSV) infection.

上海Ark生物制药有限公司（ArkBio）已正式宣布国家医疗产品管理局（NMPA）批准其创新抗体药物AK0610的研究性新药（IND）申请。这种革命性的抗体药物是生物工程的结果，源于先前从呼吸道合胞病毒（RSV）感染中恢复的儿童中发现的中和抗体。

Its primary goal is to protect infants throughout the entire RSV season.ArkBio acquired the intellectual property rights for the drug through licensing from the Institute of Microbiology, Chinese Academy of Sciences (CAS), and Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, China.

其主要目标是在整个RSV季节保护婴儿。ArkBio通过获得中国科学院微生物研究所和首都医科大学北京儿童医院，国家儿童健康中心的许可，获得了该药的知识产权。

Following the licensing, ArkBio conducted further engineering and optimization processes. The discovery and pre-clinical characterization of AK0610 were collaboratively published in hLife by Professor George Fu Gao and his team from the Institute of Microbiology, Professor Zhengde Xie and his team from Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, China, and the ArkBio R&D team.RSV, a highly prevalent and infectious RNA virus, poses a significant risk to populations, especially children, the elderly, and individuals with compromised immune systems.

获得许可后，ArkBio进行了进一步的工程和优化流程。AK0610的发现和临床前特征由George Fu Gao教授及其微生物学研究所团队，谢正德教授及其首都医科大学附属北京儿童医院，国家儿童健康中心合作发表在hLife上，中国和ArkBio研发团队。RSV是一种高度流行且具有传染性的RNA病毒，对人群，特别是儿童，老年人和免疫系统受损的个体构成重大风险。

It is a leading cause of acute lower respiratory tract infection (ALRTI) in infants globally, resulting in bronchiolitis and pneumonia. In 2019, there were 33 million reported cases of RSV-ALRTI in children under 5 years of age worldwide, with approximately 3.6 million hospitalizations and 100,000 deaths, according to Lancet.

它是全球婴儿急性下呼吸道感染（ALRTI）的主要原因，导致细支气管炎和肺炎。根据柳叶刀的数据，2019年全球5岁以下儿童报告的RSV-ALRTI病例为3300万，住院人数约为360万，死亡人数为10万。

China, in particular, has a high incidence of lower respiratory tract infection (LRTI) in children cau.

特别是中国儿童下呼吸道感染（LRTI）的发病率很高。